Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the effectiveness of EPIFLO in combination with standard wound therapy on wound healing as compared to standard wound therapy alone; and 2) Screening for potential safety issues.

Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive debridement. Subjects will be randomized to either the Treatment arm or the Control arm. Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment Period, once two weeks after wound closure and once at the end of 12-week durability Period.

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.

Device: Epiflo

During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Other Name: Transdermal Continuous Oxygen Therapy

Sham Comparator: Sham Device

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.

Other: Moist Wound Therapy

During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

20 Years to 90 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male and female patients 20-90 years of age with type 1 or type 2 diabetes mellitus with non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers of at least 4 weeks duration, but not greater than 52 weeks, measuring 1 -10 cm2 in area (Area = length x width) 50% at least from 65+ age group

Any diabetic foot ulcer at or below the malleoli

Patients with partial amputation up to & including a TMA

Subjects; between 20-90 years of age with a diabetic foot ulcer; 50% at least from 65+ age group

Subjects must have had the wound open for at least 4 weeks from day one on screening visit.

Subjects wound must be ≥1 cm2 in size at screening visit, but not greater than 10 cm2.

Subject's ABI should be ≥ 0.7 on the study limb or transcutaneous partial pressure oxygen (TcpO2) >40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistent with adequate flow in the foot(biphasic or triphasic waveforms) at screening

No active malignancy except non-melanoma skin cancer

Subject and/or caregiver must be willing and able to learn and perform the duties of dressing changes, and demonstrate the ability to do so.

If patient has had a history of alcohol or substance abuse within 6 months prior to base line period, should provide proof of treatment.